Evaluate Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 After Single Subcutaneous Injection in Healthy Chinese Volunteers
NCT07535775 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48
Last updated 2026-06-26
Summary
The goal of this study is to evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of BCD-261 after Single Subcutaneous Injection in Healthy Chinese Volunteers
Conditions
- Healthy Adult Participants
Interventions
- DRUG
-
BCD-261
Anti-TL1A human monoclonal antibody. Solution for Subcutaneous Injection.
Sponsors & Collaborators
-
SPH-BIOCAD (HK) Limited
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-05-11
- Primary Completion
- 2026-10-10
- Completion
- 2027-03-20
Countries
- China
Study Locations
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